Roche’s Breast Cancer Regimen Shows Promise

Genentech, a member of the Roche Group, achieved positive results from the NEOSPHERE trial, a Phase II neoadjuvant study evaluating a combination regimen of pertuzumab and Herceptin (trastuzumab) plus chemotherapy (docetaxel) in women with early-stage, HER2-positive breast cancer. The data showed that the two antibodies plus docetaxel, given prior to surgery, significantly improved the rate of complete tumor disappearance (pathological complete response rate of 45.8%) in the breast by more than half compared to Herceptin plus docetaxel (pCR of 29%).

The combination of pertuzumab and Herceptin plus docetaxel was not associated with a significant increase in side effects or cardiac risk compared to Herceptin and chemotherapy.

“We are committed to developing new medicines that make a difference for people living with cancer and to advancing personalized treatments,” said Hal Barron, M.D., executive vice president, Product Development and chief medical officer. “The clinical data presented today (at SABCS) add to the body of evidence that this novel targeted regimen plus chemotherapy may improve outcomes in women with HER2-positive breast cancer.”

Based on these findings, Genentech/Roche plans to initiate a Phase III study in HER2-positive early (adjuvant) breast cancer in 2011. In addition, results from a Phase III study evaluating pertuzumab and Herceptin plus chemotherapy as a first-line regimen in HER2-positive metastatic breast cancer, are expected by the end of 2011.